Hygostar IIR PP Face Masks, 3-ply, White, Made in Germany

Standards and labels

• EN 14683:2019

  EN 14683 is a European standard for face masks. It includes requirements for mask design, testing, and labeling. Test results include things like filtration efficiency and breathability. The standard also includes requirements for packaging and labeling. The 2019 version updates the previous 2014 version.

  Test results

  Bacterial Filtration Type IIR

  The Bacterial Filtration Efficiency (BFE) result for Type IIR in the standard EN 14683:2019 assesses the efficacy of medical face masks in preventing the passage of aerosolized bacteria. This is crucial for medical environments to ensure a high level of protection against potential bacterial infections transmissible through human respiratory droplets. For Type IIR under EN 14683:2019, the bacterial filtration efficiency test involves determining the percentage of bacteria-laden aerosols that do not pass through the mask material. Masks must demonstrate a BFE of ≥98% at a specified bacteria challenge load, ensuring superior filtration capabilities. This higher requirement reflects Type IIR's application in environments where exposure to blood and bodily fluids is possible, granting them suitability for surgeries and other medical proceedings where stringent sterile conditions are essential.

• Made in Germany

  "Made in Germany" is a label used to indicate that a product has been manufactured or produced in Germany. The label is not regulated by EU laws and doesn't have specific requirements, but it's an indication of quality, craftsmanship and reliability that many German companies and products are known for. However, some German companies and industries may have their own standards and certifications for the "Made in Germany" label, such as VDA for the automobile industry or TUV for the electronic products. In addition, the German government does not have any specific laws or regulations for the use of "Made in Germany" label. It is up to the companies themselves to decide if they want to use it, and if they do, it is their responsibility to ensure that the products are truly made in Germany.

• Food Safe

  Food safe refers to the safety of food products that are used or consumed by people. In Europe, food safety is regulated by the European Union (EU) and the European Food Safety Authority (EFSA). These organizations set standards and requirements for food products to ensure they are safe to eat. To be considered "food safe" in Europe, a product must meet these standards and be free of harmful substances. This includes being free of harmful bacteria, pesticides, and other contaminants. Food products that do not meet these standards cannot be sold or used in the EU.

• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.